A bench top immunoassay analyzer is considered to have medium sample throughput capability falling between POC (point of care) and high volume analyzers. Where POC instruments measure 1 or 2 samples at a time and high volume systems are capable of handling hundreds to thousands of samples, bench top analyzers with medium throughput can accommodate somewhere around the range of ten to one hundred samples. The term “bench top” used to describe these medium throughput analyzers indicates the instruments are intended to be small enough to be placed in small to mid sized clinics on laboratory benches.
One challenge to the design of a bench top analyzer is that some clinical situations demand multi-analyte capability where several markers are measured in the same sample. Multi-analyte capability can offer the user more rapid result turn around time and greater convenience with lower cost compared to running individual assays for each marker in the panel. A bench top analyzer should be capable of offering a full menu of immunoassays (over 50 assays) and many of these assays have different protocols, assay times and reagents, all of which demand that the instrument system including the consumables (disposable reagents and immunoassay devices) have the flexibility to accommodate these differing assay requirements. Another challenge is that in clinical labs, bench space is at a premium and the “foot print” of an instrument is a major consideration.
Clinical immunoassay analyzers offer a full menu of assays; they need to have all or many of the assay reagents in the menu residing in the instrument in order to be available when test panels are ordered. The storage of multiple reagent vials adds to the space and complexity of the instrument system. The fluid handling subsystem must be capable of withdrawing an aliquot from the reagent vial and dispense it into a test device along with sample. Often to achieve long term stability of the assay reagents, the storage chamber is be refrigerated. FIG. 1 shows a typical bench top analyzer manufactured by Adaltis with the reagent vials, cuvette tray and the major subsystems within the instrument. A major portion of the instrument illustrated in FIG. 1 is dedicated to storage of reagents and calibrators necessary to offer a full menu assays.
Since consumables (reagents and immunoassay devices) are central to the design of an immunoassay instrument system, there is a need for unitized consumables that keep all the essential reagents in one unit and in a dry format. The unitized consumables improve the reagent stability, reduce the complexity and overall size of a bench top analyzer, and add to user convenience.